Résumés
Abstract
This review article considers ethical concerns when doing research on potentially vulnerable people who inject drugs (PWID) in a Canadian context. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans broadly addresses many of the traditional ethical principles of research on vulnerable persons, but does so at the cost of clarity and precision. Vulnerability is contextual rather than absolute. When doing research with vulnerable persons, informed consent should be obtained from an independent person, and comprehension should be checked using questioning. Participants can be vulnerable due to many factors, including addiction, chronic disease, socioeconomic and racial status, and lack of education. The ability of PWID to give informed consent can be compromised by undue influence or intoxication, but existing research shows that neither the mode nor the magnitude of compensation has a significant effect on new rates of drug use. Compensation can also help dispel the therapeutic misconception. Intoxication rather than undue influence is the main concern when obtaining informed consent from PWID. The stigmatization of PWID as incapable of consent should be avoided. Paternalistic exclusion from research can harm PWID and exacerbate their vulnerability by reducing our knowledge of and ability to specifically treat them. As such, we must collect better data about the effects of research ethics policies. Studies to this effect should focus on experiences, perspectives and needs of potentially vulnerable research participants. Research ethics boards in Canada should adopt an evidence-based approach when applying discretionary power to proposals for clinical research.
Keywords:
- research ethics,
- informed consent,
- vulnerable,
- intravenous,
- drug users,
- harm,
- undue influence
Résumé
Cet article de revue examine les préoccupations éthiques lors de recherches menées chez les usagers potentiellement vulnérables de drogues injectables (PWID) dans un contexte canadien. L’Énoncé de politique des trois Conseils : Éthique de la recherche avec des êtres humains aborde un large éventail de principes traditionnels de l’éthique de la recherche concernant les personnes vulnérables mais le fait au détriment de la clarté et de la précision. La vulnérabilité est contextuelle plutôt qu’absolue. Dans le cadre de recherche auprès des personnes vulnérables, le consentement éclairé devrait être obtenu par une personne indépendante et la compréhension devrait être vérifiée à l’aide d’un questionnaire. Les participants peuvent être vulnérables en raison de nombreux facteurs, notamment la toxicomanie, les maladies chroniques, le statut socio-économique et ethnique et le faible niveau d’éducation. La capacité de PWID à donner un consentement éclairé peut être compromis par une influence indue ou une intoxication mais les recherches existantes montrent que ni le mode ni l’ampleur de l’indemnisation n’ont un effet significatif sur les nouveaux taux de consommation de drogues. L’indemnisation peut également contribuer à dissiper la méprise thérapeutique. L’intoxication plutôt que l’influence indue est la principale préoccupation lors de l’obtention du consentement éclairé des PWID. La stigmatisation des PWID comme incapables de consentir devrait être évitée. L’exclusion paternaliste de la recherche peut nuire aux PWID et exacerber leur vulnérabilité en réduisant notre connaissance et notre capacité à les traiter spécifiquement. En tant que tel, nous devons recueillir de meilleures données concernant les effets des politiques d’éthique de la recherche. Les études menées à ce sujet devraient être axées sur les expériences, les perspectives et les besoins des participants à la recherche qui sont potentiellement vulnérables. Les comités d’éthique de la recherche au Canada devraient adopter une approche fondée sur des preuves lors de l’application du pouvoir discrétionnaire pour les propositions en recherche clinique.
Mots-clés :
- éthique de la recherche,
- consentement éclairé,
- vulnérable,
- intraveineux,
- consommateurs de drogues,
- préjudice,
- influence indue
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